Pharmaceutical manufacturer Impax Laboratories has announced the formation of a new Compliance Committee it says will be focused on providing oversight for the company's regulated activities after the US Food and Drug Administration (FDA) identified major deficiencies at one of the company's manufacturing facilities. Background: Generic Issues Impax is coming off something of a tumultuous period. On 15 March 2013, FDA announced it would withdraw approval for the compan...

The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device consultancy Emergo Group shows that the agency is dramatically ramping up the number of quality-related deficiencies it cites in its inspection reports. Background FDA has long maintained that it has seen a troubling increase in the number of quality-related deficiencies durin...

Many pharmaceutical companies spend considerable time, resources and energy to ensure that their facilities are in top shape, wary of the potential for US regulators to issue a Form-483 identifying deficiencies at a manufacturing facility and the costs associated with correction or remediation. But if the prospect of just one Form-483 is enough to keep some regulatory affairs professionals awake at night, it's hard not to wonder how much sleep the compliance officials a...

The US Food and Drug Administration (FDA) has announced that yet another compounding pharmacy has initiated a national recall for all products manufactured at a Florida facility, explaining that an inspection of the facility last month found deficient practices that might have exposed its sterile products to microbial contamination. Background Compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without havi...

A crackdown on pharmaceutical compounders is growing ever wider, with the US Food and Drug Administration (FDA) adding another 15 inspection deficiency reports (Form 483s) to its website outlining a string of sterility problems increasingly seen as endemic throughout the industry. In the wake of similar problems uncovered in late 2012-and a surge of interest from the media-FDA has started to post all Form 483 reports related to compounding pharmacies on its website. Thos...

Generics pharmaceutical manufacturer Impax Laboratories hasn't had an easy last two weeks. On 4 March 2013, it announced that the US Food and Drug Administration (FDA) had, after conducting an inspection at its California Facility, determined that the facility had 12 deficiencies, and issued it a Form 483 . Those deficiencies sent the firm's shares plunging . Then, on 15 March 2013, FDA announced it would withdraw approval for the company's generic equivalent of bupro...

Life sciences manufacturer Novo Nordisk has been sent a Warning Letter from the US Food and Drug Administration for what regulators said were "significant" deficiencies found at the company's Bagsvaerd, Denmark facility. FDA officials said they were particularly concerned about current good manufacturing practice (CGMP) violations found at the firm, which included practice deviations that could have potentially led to product being manufactured under non-sterile condit...

A South Korean medical device company is at the receiving end of a particularly blunt warning letter in which US regulators accuse the company of fixing almost none of the problems they found during a 2010 inspection. The 26 November 2012 letter to Seoul-based Sometech Incorporated, manufacturer of medical imaging equipment and high-frequency surgical instruments, references an April 2012 inspection by the US Food and Drug Administration (FDA). During that inspectio...

Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...

Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis. The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 release...

The US Food and Drug Administration (FDA) has identified a number of troubling lapses in good manufacturing practices at the New England Compounding Center ( NECC ), the Massachusetts-based pharmaceutical compounding facility now linked to a massive outbreak of fungal meningitis, after an inspection revealed widespread and unaddressed sterility problems. Regulators released a Form 483 , a form FDA uses to list potential violations of the Federal Food, Drug and Cosmet...

The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...